Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901731800445 Date of Registration: 30/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Zentangle Art Therapy (ZART) Brain Health Program
Official scientific title Effect of visual art therapy based on Zentangle methods on cognitive and psychological function among older adults with mild cognitive impairment. A randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Cognitive impairment is a global public health concern due to its association with disability and dependency among elderly population (World Health Organization 2017). Currently 50 million people globally live with dementia, and is expected that by the year 20150, 152 million people will be affected (World Health Organization 2017). The impact is ought to be much worse in the rural settings of developing countries like Tanzania which comprise of a higher share of older adults with higher rates of technological illiteracy, poverty and less access to health and social services. (Help Age International 2011; URT 2014). Art therapies have demonstrated some cognitive and psychological benefits to older adults with dementia (Beard, 2012). However, less evidence exists of the immediate and lasting health impacts to patients with suboptimal cognitive function (Mild cognitive function (MCI)). The objective of our study is to test the health impacts of the visual art therapy using Zentangle™ methods on the health outcomes of MCI patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mild Cognitive Impairment - MCI
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 14/01/2019
Actual trial start date 21/01/2019
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 28/12/2019
Anticipated target sample size (number of participants) 142
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Not yet available
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Visual art therapy using Zentangle methods Participants in the intervention group will receive twelve sessions of visual art therapy. Sessions will be delivered twice weekly for six weeks. The total time for intervention will be six weeks Participants in the intervention group will receive visual art therapy using Zentangle methods (Roberts and Thomas 2012). This involves creation of beautiful images by drawing structured patterns using basic ingredients of lines, shapes, space, form, texture, color and value. Traditionally this process occurs in the quiet venue, with soothing music playing in the background and the group art therapy sessions are facilitated by the trained artist (Zentangle inc. n.d.). In this study, the therapy will be delivered by the researcher who have undergone training by Zentangle inc, Hong Kong branch, on skills of delivering art therapy using Zentangle methods; possess facilitation skills, experienced in training adults and has been given permission and support by Zentangle™, Inc. USA to use the methods for this research. Participants assigned to intervention group will attend 12 sessions of group art therapy using Zentangle methods. Sessions will be administered to each small group for 2 hours twice weekly for six weeks. The intervener will administer treatment intervention according to Prescribed protocol. Participants will be asked not to share their materials to other people outside their group before the end of research to minimize the possibility for contamination. On the first day, there will be an introductory session that will cover mutual goal setting of group norms, expectations, orientation on Zentangle art materials and principles, and then practice on the basic patterns in creating artworks. Participants will produce new artwork on each therapy day and level of complexity and creativity of the artwork will increase every day following the daily therapy protocol. The first six sessions will be divided into 20 minutes’ brief introduction of day’s objective, review of Zentangle art ingredients and principles, then 80 minutes art making with guidance of the facilitator. The last 20 minutes will be used for sharing and appreciating one another’s art work. 71
Control Group Health education not related to brain health Six sessions will be delivered to the control group. Participants in the control group will attend health education session once weekly for six weeks. Six weeks The control group will receive a six weekly health education related to prevention of communicable diseases (malaria, tuberculosis and HIV) which are more prevalent in the Tanzanian population (NBS- Tanzania, 2013) but do not relate to brain health. The control intervention will be delivered by a qualified research assistant who possess an MSc Nursing. Control intervention will occur at different centers from that of intervention groups and participants will be asked not to share their materials to other people outside their group before the end of research. 71 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Older adult ≥ 60 years old, living in the community in Chamwino district, Dodoma region in Tanzania. Diagnosis of MCI as per DSM-IV criteria for minor neurocognitive disorder (as clinically assessed by the psychiatrist), not meeting the DSM-IV criteria for major neurocognitive disorder and functional independence as assessed by Katz ADL index (Petersen 2004; 2009). Must consent to participate in the study, and able to travel to the venue and participate in 12 sessions of art therapy. Participants who report significant impairments in hearing and/ or visual Those who regularly practice visual art Those who have severe physical illness 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/01/2019 Joint Chinese University of Hong Kong New Territory East Cluster Clinical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Prince of Wales Hospital, Shatin, Hong Kong Hong Kong 518000 Hong Kong
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/01/2019 University of Dodoma Institutional Research Review Committee
Ethics Committee Address
Street address City Postal code Country
Administrative Building, The University of Dodoma Dodoma 00255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cognitive function - measured using Tanzanian version of Montreal Cognitive Assessment (T-MoCA), Modified from the original Kiswahili version of MoCA after its validation demonstrated less utility and needed modification, Translated 5 minutes protocol of Hong Kong MoCA and IDEA Cognitive screening Baseline, immediate after the intervention, at 3 months follow up post intervention and at 6 months follow up post intervention
Secondary Outcome Depressive symptoms measured by Kiswahili-Short-form Geriatric Depression Scale (K-GDS-SF) Emotional Wellbeing measured by Mental Health Inventory (MHI-5) Instrumental activities of daily living (IADL) measured by Kiswahili-Lawton-IADL Baseline, immediate after intervention, 3 months follow up post intervention and 6 months follow up post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Buigiri Centre Located at local government offices of the Buigiri ward Chamwino district of Dodoma region United Republic of Tanzania
Manchali centre Located at local government offices of the Manchali ward Chamwino district of Dodoma region United Republic of Tanzania
Chalinze Centre Located at the Chalince village government offices Chamwino district of Dodoma region United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The University of Dodoma Administrative Building, The University of Dodoma Dodoma 00255 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Dodoma Administrative building, The University of Dodoma Dodoma 00255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Prof. Doris S.F YU The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territory Hong Kong 518000 Hong Kong
Dr. Stephen Kibusi School of Nursing and Public Health, College of Health and Allied Sciences, University of Dodoma Dodoma 00255 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Golden Mwakibo Masika golden.masika@link.cuhk.edu.hek +85239433513 The Nethersole School of Nursing, The Chinese University of Hong Kong, ELB/ 6F/ R601 Shatin, New Territory
City Postal code Country Position/Affiliation
Hong Kong 518000 Hong Kong PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Doris S.F. YU dyu@cuhk.edu.hk +85239434289 The Nethersole School of Nursing, The Chinese University of Hong Kong Shatin, New Territory
City Postal code Country Position/Affiliation
Hong Kong Hong Kong Professor and Supervisor
Role Name Email Phone Street address
Public Enquiries Stephen Kibusi skibusi@gmail.com +255712600966 School of Nursing and Public Health, College of Health and Allied Sciences, The University of Dodoma
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Site Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information